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Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma

NCT04975152 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-05

No results posted yet for this study

Summary

The goal of this clinical research study is to determine if Cemiplimab-rwlc (called Cemiplimab in this document) given prior to tumor resection surgery is safe and effective in treating (1) Merkel Cell Carcinoma or (2) Cutaneous Squamous Cell Carcinoma (CSCC).

Conditions

Interventions

DRUG

Cemiplimab-Rwlc

Flat dose of cemiplimab-rwlc 350 mg IV every 3 weeks, up to 9 cycles.

Sponsors & Collaborators

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Ahmad Tarhini, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04975152 on ClinicalTrials.gov